A Study of Azithromycin in HIV-Infected Patients

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Azithromycin

About this trial

This is an interventional treatment trial for Bacterial Infections focused on measuring Azithromycin, Bacterial Infections

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Patients must have: HIV seropositivity. CD4 count <= 500 cells/mm3. NO active AIDS opportunistic infection. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Other active intercurrent illness. Any condition possibly affecting drug absorption (e.g., ulcers, gastrectomy, HIV-associated enteropathies. Signs or symptoms of severe illness that would preclude study participation. Known allergies to macrolide antibiotics. Patients with the following prior condition are excluded: Clinically important change in baseline status within 4 weeks prior to study entry. Prior Medication: Excluded: Investigational drugs including treatment IND drugs within 4 weeks prior to study entry. Known drug or alcohol dependence.

Sites / Locations

Harris Laboratories Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002344

First Posted

November 2, 1999

Last Updated

June 23, 2005

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00002344

Brief Title

A Study of Azithromycin in HIV-Infected Patients

Official Title

Double-Blind Crossover Study Assessing the Dose Proportionality of Azithromycin Tablets in HIV-Infected Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

April 1996

Overall Recruitment Status

Completed

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

5. Study Description

Brief Summary

To assess the dose proportionality of azithromycin concentrations and toleration when delivered in tablet formulation to HIV-infected patients. The need exists to further assess the antibacterial agent azithromycin at differing doses in an HIV-infected population.

Detailed Description

The need exists to further assess the antibacterial agent azithromycin at differing doses in an HIV-infected population. Patients are randomized to receive azithromycin at 1 of 2 doses in a two-treatment, two-period, cross-over study. Dosing visits are separated by at least 14-day wash-out periods.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bacterial Infections, HIV Infections

Keywords

Azithromycin, Bacterial Infections

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Enrollment

12 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Azithromycin

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria Patients must have: HIV seropositivity. CD4 count <= 500 cells/mm3. NO active AIDS opportunistic infection. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Other active intercurrent illness. Any condition possibly affecting drug absorption (e.g., ulcers, gastrectomy, HIV-associated enteropathies. Signs or symptoms of severe illness that would preclude study participation. Known allergies to macrolide antibiotics. Patients with the following prior condition are excluded: Clinically important change in baseline status within 4 weeks prior to study entry. Prior Medication: Excluded: Investigational drugs including treatment IND drugs within 4 weeks prior to study entry. Known drug or alcohol dependence.

Facility Information:

Facility Name

Harris Laboratories Inc

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85040

Country

United States

Bacterial Infections, HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial